Government-Owned Inventions; Availability for Licensing, 21372-21374 [E9-10549]
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21372
Federal Register / Vol. 74, No. 87 / Thursday, May 7, 2009 / Notices
Electronic comments or submissions
will be accepted by FDA only at https://
www.regulations.gov.
Dated: April 30, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–10555 Filed 5–6–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; NHLBI Health Information
Center’s Revolving Customer
Satisfaction Survey
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Heart, Lung and Blood
Institute (NHLBI), the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: NHLBI
Health Information Center’s Revolving
Customer Satisfaction Survey. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
The purpose of this survey is to identify
those areas in which services provided
by the NHLBI Health Information Center
(HIC) to health professionals, patients
and their families, and the general
public are outstanding and areas where
improvements are needed. That
information will be used to formulate
programs, processes, training, and
Estimated
number of
respondents
Type of respondent
enhancements to raise the level of
customer satisfaction with the services
provided by the NHLBI HIC. With
subsequent surveys, data will
demonstrate whether gains have been
made in areas for improvement and if
new customer needs must be addressed.
Frequency of Response: Twice a year.
Affected Public: Individuals. Type of
Respondents: Individuals who contact
the NHLBI HIC by telephone or e-mail
during each 1-month data collection
period. The annual reporting burden is
as follows: Estimated Number of
Respondents: 99; Estimated Number of
Responses per Respondent: 1; Average
Burden Hours per Response: 0.05; and
Estimated Total Annual Burden Hours
Requested: 9.9. The annualized cost to
respondents is estimated at: $242.15.
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Annual
frequency of
response
Average
burden hours
per response
Estimated
total annual
burden hours
requested
General Public .................................................................................................
Private Companies ..........................................................................................
Public Sector Groups .......................................................................................
Health Professionals ........................................................................................
43
14
13
29
2
2
2
2
0.05
0.05
0.05
0.05
4.3
1.4
1.3
2.9
Totals ........................................................................................................
99
........................
........................
9.9
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Ann M.
Taubenheim, Principal Investigator,
National Heart, Lung, and Blood
Institute, Office of Communications and
Legislative Activities, NIH, 31 Center
VerDate Nov<24>2008
17:03 May 06, 2009
Jkt 217001
Drive, Building 31, Room 4A10,
Bethesda, MD 21045, or call non-tollfree number 301–496–4236 or e-mail
your request, including your address, to
taubenha@nhlbi.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: April 28, 2009.
Ann M. Taubenheim,
Principal Investigator, NHLBI.
[FR Doc. E9–10586 Filed 5–6–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
35 U.S.C. 207 to achieve expeditious
commercialization of results of federally
funded research and development.
Foreign patent applications are filed on
selected inventions to extend market
coverage for companies and may also be
available for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
National Institutes of Health
Novel Inhibitors of Bone Morphogenetic
Proteins
Government-Owned Inventions;
Availability for Licensing
Description of Technology: Bone
Morphogenetic Proteins (BMPs) are
signaling molecules that are central in a
variety of biological processes, but were
first recognized for their role in
inducing bone and cartilage
development. Abnormal BMP signaling
has been implicated in the pathogenesis
of a class of joint disorders known as
spondyloarthropathies which includes
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
PO 00000
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07MYN1
Federal Register / Vol. 74, No. 87 / Thursday, May 7, 2009 / Notices
ankylosing spondylitis, psoriatic
arthritis, reactive arthritis, and arthritis
associated with inflammatory bowel
disease. Therefore, inhibitors and
modulators of BMP signaling may be
useful in managing these disorders.
Moreover, the BMPs and their
antagonists have now been implicated
in myriad cell and tissue differentiation
and fate specification processes,
extending their utility far beyond
orthopedic and rheumatologic
applications. Scientists at the Food and
Drug Administration, National Institutes
of Health and Katholieke Universiteit
Leuven have discovered a novel
inhibitor of BMPs called Secreted
Modular Calcium Binding protein
(SMOC) which is unrelated to known
BMP inhibitors.
This technology relates to a method
for treating disorders including joint
disorders by administering a SMOC
polypeptide to induce intracellular
mitogen activated protein (MAP) kinase
activity to effect a reduction of BMP
signaling activity in the cells of a
patient. It also encompasses methods to
manipulate differentiation processes
regulated by BMPs. One prominent
example is the specification of neural,
as opposed to epithelial, cell fate.
Applications
• Treatment of joint diseases.
• Manipulation of tissue fate
specification in vitro, alone or in
combination with other materials, in
production of therapeutic cells and
tissues.
Advantages
• Ability to interrupt BMP signaling
by a novel mechanism;
• Predictable synergy with other BMP
antagonists;
• No indication of being
immunosuppressive;
• In some instances SMOC is
associated with extracellular matrix
molecules, allowing for spatially
restricted BMP antagonism not possible
with diffusible factors such as noggin.
Development Status: Early stage.
Market: Modulation of BMP signaling
by secreted inhibitors is involved in
formation of the body axis, limbs and
joints, all organs, and nervous tissue, to
name a few. The applications of SMOC
in conjunction with other growth factors
in vitro in various developmental
programs to produce therapeutic cells
and/or tissues are therefore numerous.
In addition, BMPs are involved in many
disorders in man, and modulating their
activities may provide a therapeutic
benefit for a number of diseases and
disorders such as arthritis and
spondyloarthropathies.
VerDate Nov<24>2008
17:03 May 06, 2009
Jkt 217001
Inventors: Malcolm C. Moos et al.
(CBER/FDA), Frank P. Luyten (NIDCR).
Publications: None related to this
invention.
Patent Status: U.S. Provisional
Application No. 61/086,679 filed 06
Aug 2008 (HHS Reference No. E–338–
2005/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Surekha Vathyam,
PhD; 301–435–4076;
vathyams@mail.nih.gov.
Salcut-NH2: A Novel Target for
Development of Anti-Tumorigenic,
Anti-Angiogenic Therapeutics and
Diagnostics
Description of Technology: SalcutNH2, a novel amidated peptide derived
from the Apelin proprotein, is shown to
induce the proliferation of cells.
Uncontrolled cell proliferation is the
salient feature of cancer. Thus,
therapeutics that stop this aberrant cell
division are very desirable. Salcut-NH2
can be the basis for developing novel
inhibitors of cancer growth such as
modified peptide antagonists like
salcut-glycine (salcut-Gly). Alternately,
salcut-NH2 could be the target of
antibody therapies that block its
activity. In some instances, such as
wound healing, inducing cell
proliferation would be advantageous. It
also has been demonstrated that salcutNH2 induces angiogenesis so it may also
have application as a topically
administered therapeutic for speeding
the healing of skin wounds. Finally,
increasing levels of salcut-NH2 in body
fluids may be reflective of disease
progression. A diagnostic kit for salcutNH2 could potentially be developed for
the prognosis of a variety of diseases
associated with aberrant cell
proliferation or angiogenesis.
Applications
• Development of therapeutics that
inhibit cancer growth or diseases related
to aberrant angiogenesis.
• Topical therapeutic to hasten
wound healing.
• Diagnostic for the prognosis of
cancer or diseases related to aberrant
growth of blood vessels.
Advantages
• Naturally derived peptide and thus
negligible immunogenicity.
• Amidation makes salcut-NH2
resistant to proteases and increases its
availability.
• Small peptides are readily excreted
facilitating measurement of salcut-NH2
for diagnostic purposes.
Development Status: Early stage; preclinical data available.
PO 00000
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21373
Markets:
• Cancer is the second most common
cause of death in the U.S., exceeded
only by heart disease. In the U.S., cancer
accounts for 1 of every 4 deaths and
more than 2.4 million new cancer cases
were expected to be diagnosed in 2008.
• Age-related macular degeneration
(AMD) is a degenerative disease of the
retina that eventually leads to a loss of
vision. The wet form of AMD is the
most common and is characterized by
the abnormal growth of retina blood
vessels and results in a rapid loss of
central vision. It is estimated that AMD
affects 1.75 million people in the United
States.
Inventors: Frank Cuttitta et al. (NCI).
Publications: None related to this
invention.
Patent Status: U.S. Provisional
Application No. 61/156,351 filed 27 Feb
2009 (HHS Reference No. E–179–2008/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Surekha Vathyam,
PhD; 301–435–4076;
vathyams@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute
Angiogenesis Core Facility is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize (1) Identification of new
biological functions for Salcut-NH2 or
(2) Development of compounds that
suppress or augment Salcut-NH2
bioactivity. Please contact John D.
Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Novel Oligonucleotides for Treatment
of Human Cancer
Description of Technology: Human
endogenous retroviruses (HERVs) are
remnants of retroviruses that invaded
and integrated into the human genome
6–15 million years ago. One significant
type of HERV is ERV–9; approximately
5% of the total human genome
comprises sequences from this
retrovirus family. The human genome
contains approximately 50 copies of
ERV–9 along with 3000–4000 copies of
solitary elements of ERV–9 regulatory
regions, called long terminal repeats
(LTRs). The solitary LTRs contain
promoter and enhancer elements that
drive expression of genes located
proximally to the LTR. Therefore,
insertion of an ERV–9 LTR proximal to
an oncogene could initiate
carcinogenesis.
This invention relates to the use of
antisense and sense oligonucleotides
(oligos) targeting the RNAs of ERV–9
E:\FR\FM\07MYN1.SGM
07MYN1
21374
Federal Register / Vol. 74, No. 87 / Thursday, May 7, 2009 / Notices
LTR as a treatment for various cancers,
including human breast, liver, prostate,
and myeloid cancers and fibrosarcomas.
The inventors have shown that the
ERV–9 LTR sense and antisense oligos
can inhibit cancer cell proliferation in
vitro more efficiently than the antisense
oligos of Bcl-2 (G3139) and telomerase
(GRN163), both of which are currently
in cancer clinical trials. The oligos have
minimal effects on the proliferation of
primary normal human cells in vitro.
These oligos have potential as a new
therapeutic agent to suppress tumor cell
growth, either when used alone or in
conjunction with other antisense oligos
or with chemotherapeutic agents such
as VePesid. Furthermore, sense and
antisense RNA transcripts of ERV–9
LTR were detected in many human
normal and tumor cells in this
invention. The sense and antisense RNA
may form double stranded RNA and act
as siRNA to regulate gene expression.
Applications
• Therapeutic oligos of the invention
can be used to treat variety of cancers
including, but not limited to, breast,
liver, myeloid and prostate cancers and
fibrosarcomas.
• The oligos can be used either singly
or as adjuvant therapy with
chemotherapeutic agents.
• ERV–9 LTR related cancers can be
diagnosed by comparative analysis of
the levels of ERV–9 LTR RNAs in
tumors versus those of healthy tissues.
Advantages
• Greater inhibition of cell
proliferation by oligos of the invention
compared to the Bcl-2, telomerase and
MDM2-specific antisense oligos which
are currently in development as cancer
therapies.
• The therapeutic effect of the oligos
is specific for cancer cells as the oligos
do not significantly alter proliferation of
normal human cells.
Development Status: In vivo testing of
therapeutic sense and antisense oligos
in mouse xenograft models has been
successfully conducted.
Market: Cancer is the second leading
cause of death in the United States.
More than 1 million Americans are
diagnosed with cancer each year.
Inventors: Lai Xu (FDA/CDER), Abdel
Elkahloun (NHGRI), Fabio Candotti
(NHGRI), Amy Rosenberg. (FDA/CDER)
Publications: None related to
invention have been published.
Patent Status: U.S. Provisional
Application No. 61/191,911 filed 11 Sep
2008 (HHS Reference No. E–092–2008/
0–US–01).
Licensing Status: Available for
licensing.
VerDate Nov<24>2008
17:03 May 06, 2009
Jkt 217001
Licensing Contact: Surekha Vathyam,
PhD; 301–435–4076;
vathyams@mail.nih.gov.
Dated: April 30, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–10549 Filed 5–6–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Cancer
Pathobiology ARRA CR.
Date: May 19, 2009.
Time: 2 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Alexandria Old Town, 1767
King Street, Alexandria, VA 22314.
Contact Person: Elaine Sierra-Rivera, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6184,
MSC 7804, Bethesda, MD 20892. 301–435–
1779. riverase@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics; Integrated
Review Group, Biochemistry and Biophysics
of Membranes Study Section.
Date: May 28–29, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Dupont Hotel, 1500 New
Hampshire Avenue, NW., Washington, DC
20036.
Contact Person: Nuria E. Assa-Munt, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4164,
PO 00000
Frm 00064
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MSC 7806, Bethesda, MD 20892, (301) 451–
1323, assamunu@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics; Integrated
Review Group, Macromolecular Structure
and Function—B Study Section.
Date: May 28–29, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street, NW., Washington, DC 20037.
Contact Person: Arnold Revzin, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4146,
MSC 7824, Bethesda, MD 20892, (301) 435–
1153, revzina@csr.nih.gov.
Name of Committee: Immunology
Integrated Review Group; Cellular and
Molecular Immunology—A Study Section.
Date: May 28–29, 2009.
Time: 8:30 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Crystal City, 2399 Jefferson
Davis Highway, Arlington, VA 22202.
Contact Person: Samuel C. Edwards, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4200,
MSC 7812, Bethesda, MD 20892. (301) 435–
1152. edwardss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Bioengineering Member Conflicts.
Date: May 29, 2009.
Time: 10 a.m. to 11 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Ping Fan, MD, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5154,
MSC 7840, Bethesda, MD 20892. 301–435–
1740. fanp@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: April 30, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–10529 Filed 5–6–09; 8:45 am]
BILLING CODE 4140–01–M
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 74, Number 87 (Thursday, May 7, 2009)]
[Notices]
[Pages 21372-21374]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10549]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
ADDRESSES: Licensing information and copies of the U.S. patent
applications listed below may be obtained by writing to the indicated
licensing contact at the Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A
signed Confidential Disclosure Agreement will be required to receive
copies of the patent applications.
Novel Inhibitors of Bone Morphogenetic Proteins
Description of Technology: Bone Morphogenetic Proteins (BMPs) are
signaling molecules that are central in a variety of biological
processes, but were first recognized for their role in inducing bone
and cartilage development. Abnormal BMP signaling has been implicated
in the pathogenesis of a class of joint disorders known as
spondyloarthropathies which includes
[[Page 21373]]
ankylosing spondylitis, psoriatic arthritis, reactive arthritis, and
arthritis associated with inflammatory bowel disease. Therefore,
inhibitors and modulators of BMP signaling may be useful in managing
these disorders. Moreover, the BMPs and their antagonists have now been
implicated in myriad cell and tissue differentiation and fate
specification processes, extending their utility far beyond orthopedic
and rheumatologic applications. Scientists at the Food and Drug
Administration, National Institutes of Health and Katholieke
Universiteit Leuven have discovered a novel inhibitor of BMPs called
Secreted Modular Calcium Binding protein (SMOC) which is unrelated to
known BMP inhibitors.
This technology relates to a method for treating disorders
including joint disorders by administering a SMOC polypeptide to induce
intracellular mitogen activated protein (MAP) kinase activity to effect
a reduction of BMP signaling activity in the cells of a patient. It
also encompasses methods to manipulate differentiation processes
regulated by BMPs. One prominent example is the specification of
neural, as opposed to epithelial, cell fate.
Applications
Treatment of joint diseases.
Manipulation of tissue fate specification in vitro, alone
or in combination with other materials, in production of therapeutic
cells and tissues.
Advantages
Ability to interrupt BMP signaling by a novel mechanism;
Predictable synergy with other BMP antagonists;
No indication of being immunosuppressive;
In some instances SMOC is associated with extracellular
matrix molecules, allowing for spatially restricted BMP antagonism not
possible with diffusible factors such as noggin.
Development Status: Early stage.
Market: Modulation of BMP signaling by secreted inhibitors is
involved in formation of the body axis, limbs and joints, all organs,
and nervous tissue, to name a few. The applications of SMOC in
conjunction with other growth factors in vitro in various developmental
programs to produce therapeutic cells and/or tissues are therefore
numerous. In addition, BMPs are involved in many disorders in man, and
modulating their activities may provide a therapeutic benefit for a
number of diseases and disorders such as arthritis and
spondyloarthropathies.
Inventors: Malcolm C. Moos et al. (CBER/FDA), Frank P. Luyten
(NIDCR).
Publications: None related to this invention.
Patent Status: U.S. Provisional Application No. 61/086,679 filed 06
Aug 2008 (HHS Reference No. E-338-2005/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Surekha Vathyam, PhD; 301-435-4076;
vathyams@mail.nih.gov.
Salcut-NH2: A Novel Target for Development of Anti-Tumorigenic, Anti-
Angiogenic Therapeutics and Diagnostics
Description of Technology: Salcut-NH2, a novel amidated peptide
derived from the Apelin proprotein, is shown to induce the
proliferation of cells. Uncontrolled cell proliferation is the salient
feature of cancer. Thus, therapeutics that stop this aberrant cell
division are very desirable. Salcut-NH2 can be the basis for developing
novel inhibitors of cancer growth such as modified peptide antagonists
like salcut-glycine (salcut-Gly). Alternately, salcut-NH2 could be the
target of antibody therapies that block its activity. In some
instances, such as wound healing, inducing cell proliferation would be
advantageous. It also has been demonstrated that salcut-NH2 induces
angiogenesis so it may also have application as a topically
administered therapeutic for speeding the healing of skin wounds.
Finally, increasing levels of salcut-NH2 in body fluids may be
reflective of disease progression. A diagnostic kit for salcut-NH2
could potentially be developed for the prognosis of a variety of
diseases associated with aberrant cell proliferation or angiogenesis.
Applications
Development of therapeutics that inhibit cancer growth or
diseases related to aberrant angiogenesis.
Topical therapeutic to hasten wound healing.
Diagnostic for the prognosis of cancer or diseases related
to aberrant growth of blood vessels.
Advantages
Naturally derived peptide and thus negligible
immunogenicity.
Amidation makes salcut-NH2 resistant to proteases and
increases its availability.
Small peptides are readily excreted facilitating
measurement of salcut-NH2 for diagnostic purposes.
Development Status: Early stage; pre-clinical data available.
Markets:
Cancer is the second most common cause of death in the
U.S., exceeded only by heart disease. In the U.S., cancer accounts for
1 of every 4 deaths and more than 2.4 million new cancer cases were
expected to be diagnosed in 2008.
Age-related macular degeneration (AMD) is a degenerative
disease of the retina that eventually leads to a loss of vision. The
wet form of AMD is the most common and is characterized by the abnormal
growth of retina blood vessels and results in a rapid loss of central
vision. It is estimated that AMD affects 1.75 million people in the
United States.
Inventors: Frank Cuttitta et al. (NCI).
Publications: None related to this invention.
Patent Status: U.S. Provisional Application No. 61/156,351 filed 27
Feb 2009 (HHS Reference No. E-179-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Surekha Vathyam, PhD; 301-435-4076;
vathyams@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Angiogenesis Core Facility is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize (1) Identification of new
biological functions for Salcut-NH2 or (2) Development of compounds
that suppress or augment Salcut-NH2 bioactivity. Please contact John D.
Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more information.
Novel Oligonucleotides for Treatment of Human Cancer
Description of Technology: Human endogenous retroviruses (HERVs)
are remnants of retroviruses that invaded and integrated into the human
genome 6-15 million years ago. One significant type of HERV is ERV-9;
approximately 5% of the total human genome comprises sequences from
this retrovirus family. The human genome contains approximately 50
copies of ERV-9 along with 3000-4000 copies of solitary elements of
ERV-9 regulatory regions, called long terminal repeats (LTRs). The
solitary LTRs contain promoter and enhancer elements that drive
expression of genes located proximally to the LTR. Therefore, insertion
of an ERV-9 LTR proximal to an oncogene could initiate carcinogenesis.
This invention relates to the use of antisense and sense
oligonucleotides (oligos) targeting the RNAs of ERV-9
[[Page 21374]]
LTR as a treatment for various cancers, including human breast, liver,
prostate, and myeloid cancers and fibrosarcomas. The inventors have
shown that the ERV-9 LTR sense and antisense oligos can inhibit cancer
cell proliferation in vitro more efficiently than the antisense oligos
of Bcl-2 (G3139) and telomerase (GRN163), both of which are currently
in cancer clinical trials. The oligos have minimal effects on the
proliferation of primary normal human cells in vitro. These oligos have
potential as a new therapeutic agent to suppress tumor cell growth,
either when used alone or in conjunction with other antisense oligos or
with chemotherapeutic agents such as VePesid. Furthermore, sense and
antisense RNA transcripts of ERV-9 LTR were detected in many human
normal and tumor cells in this invention. The sense and antisense RNA
may form double stranded RNA and act as siRNA to regulate gene
expression.
Applications
Therapeutic oligos of the invention can be used to treat
variety of cancers including, but not limited to, breast, liver,
myeloid and prostate cancers and fibrosarcomas.
The oligos can be used either singly or as adjuvant
therapy with chemotherapeutic agents.
ERV-9 LTR related cancers can be diagnosed by comparative
analysis of the levels of ERV-9 LTR RNAs in tumors versus those of
healthy tissues.
Advantages
Greater inhibition of cell proliferation by oligos of the
invention compared to the Bcl-2, telomerase and MDM2-specific antisense
oligos which are currently in development as cancer therapies.
The therapeutic effect of the oligos is specific for
cancer cells as the oligos do not significantly alter proliferation of
normal human cells.
Development Status: In vivo testing of therapeutic sense and
antisense oligos in mouse xenograft models has been successfully
conducted.
Market: Cancer is the second leading cause of death in the United
States. More than 1 million Americans are diagnosed with cancer each
year.
Inventors: Lai Xu (FDA/CDER), Abdel Elkahloun (NHGRI), Fabio
Candotti (NHGRI), Amy Rosenberg. (FDA/CDER)
Publications: None related to invention have been published.
Patent Status: U.S. Provisional Application No. 61/191,911 filed 11
Sep 2008 (HHS Reference No. E-092-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Surekha Vathyam, PhD; 301-435-4076;
vathyams@mail.nih.gov.
Dated: April 30, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-10549 Filed 5-6-09; 8:45 am]
BILLING CODE 4140-01-P
